NCT01985490

Brief Summary

Fovea is characterized by its vessel-free zone, called foveal avascular zone and it can be visualized by fluorescein angiography. Removal of epiretinal membrane and internal limiting membrane is frequently performed procedure and we suspected that these procedures may affect integrity of foveal avascular zone. The purpose of the present study is to evaluate the change of foveal avascular zone after removal of epiretinal membrane and internal limiting membrane

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

November 10, 2013

Last Update Submit

November 25, 2013

Conditions

Epiretinal Membrane

Keywords

epiretinal membranefoveal avascular zoneinternal limiting membrane

Outcome Measures

Primary Outcomes (1)

  • area of foveal avascular zone

    the change in area of foveal avascular zone at postoperative 6 months

    postoperative 6 months

Secondary Outcomes (3)

  • change in visual acuity

    postoperative 6 months

  • change in macular thickness

    at 6 months

  • change in metamorphopsia

    postoperative 6 months

Study Arms (1)

epiretinal membrane

EXPERIMENTAL
Procedure: epiretinal membrane and internal limiting membrane removal

Interventions

epiretinal membrane and internal limiting membrane removalPROCEDURE

fluorescein angiography is performed before, 1 week, 3months and 6months after the epiretinal membrane and internal limiting membrane removal.

epiretinal membrane

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • epiretinal membrane

You may not qualify if:

  • history of vitrectomy, intraocular surgery
  • any macular disease other than epiretinal membrane
  • media opacity obscuring the image of fluorescein angiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Se Woong Kang, MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Se Woong Kang, MD

CONTACT

82-2-3410-3562swkang@skku.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2013

First Posted

November 15, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

May 1, 2015

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

KR(1)